Breast Cancer Clinical Trial

Women In Steady Exercise Research – Window of Opportunity for Exercise and Tumor Biology

Summary

The primary aim is to examine changes in tumor perfusion, oxygen saturation, and tumor physiology before and following acute physical activity in breast cancer patients.

The secondary aim is to examine changes in circulating tumor DNA (ctDNA) levels before and following acute physical activity in breast cancer patients.

The tertiary aim is to explore changes in circulating exerkines (cytokines and growth factors altered by exercise) before and following acute physical activity in breast cancer patients.

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Full Description

The proposed study seeks to leverage acute exercise physiology as a tool to better understand multiple clinical and mechanistic issues in exercise oncology. An acute exercise bout causes functional changes such as increases in heart rate and stroke volume leading to increased cardiac output and increased systemic blood flow. These systemic effects also increase tumor blood flow (perfusion). Additionally, an increase in mean arterial pressure increases oxygen diffusion distance within the tumor. Further, acute exercise mobilizes NK cells, cytokine signaling, and a myriad of other molecular and cellular transducers of exercise. Our study of acute exercise physiology in breast cancer patients will address several significant knowledge gaps both clinically and mechanistically.

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Eligibility Criteria

Inclusion Criteria:

Newly diagnosed breast cancer patients
Breast tumor is more than 2 cm (T2)
With or without lymph node involvement (N0-3)
With or without metastases (M0-M1)
No initiation of neoadjuvant treatment
Pre-surgical breast resection

Exclusion Criteria:

Current use of anticoagulants, including Vitamin K antagonists (e.g. Warfarin), Direct Oral Anticoagulants (DOACs) (e.g. Pradaxa, Eliquis, Xarelto, Bevyxxa, Savaysa), low molecular weight heparins (LMWH), Fragmin, Lovenox, heparin.
Body weight <100 lbs
Tis, T0, T1
Started neoadjuvant therapy

Absolute contraindications for exercise stress testing by self-report:

acute myocardial infarction (3-5 days)
unstable angina
uncontrolled arrhythmias causing symptoms or hemodynamic compromise
syncope
acute endocarditis
acute myocarditis or pericarditis
uncontrolled heart failure
acute pulmonary embolus or pulmonary infarction
thrombosis of lower extremities
suspected dissecting aneurysm
uncontrolled asthma
pulmonary edema
room air desaturation at rest ≤85%
respiratory failure
acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
mental impairment leading to inability to cooperate
decisional impairment
Non-English speaking
Pregnant women
Children

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT05428709

Recruitment Status:

Recruiting

Sponsor:

Milton S. Hershey Medical Center

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There is 1 Location for this study

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Penn State Hershey Medical Center
Hershey Pennsylvania, 17033, United States More Info
Kathleen M Sturgeon, PhD
Contact
717-531-0003
[email protected]
Dan Lin, MS
Contact
[email protected]

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Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT05428709

Recruitment Status:

Recruiting

Sponsor:


Milton S. Hershey Medical Center

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